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Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study

NCT05274386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-25

No results posted yet for this study

Summary

The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.

Conditions

  • Neonatal Respiratory Distress
  • Very Low Birth Weight Infant

Interventions

DEVICE

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s

The SpO2 averaging time will be set to 4to6 s for the next 12 hours.

DEVICE

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s

The SpO2 averaging time will be set to 10 s for the next 12 hours.

DEVICE

Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s

The SpO2 averaging time will be set to 16 s for the next 12 hours.

Sponsors & Collaborators

  • Motol University Hospital

    collaborator OTHER

  • Czech Technical University in Prague

    lead OTHER

Principal Investigators

  • Jan Janota, PhD · Motol University Hospital

  • Thomas E Bachman, MSc · Czech Technical University in Prague

  • Veronika Rafl-Huttova, MSc · Czech Technical University in Prague

  • Jakub Rafl, PhD · Czech Technical University in Prague

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05274386 on ClinicalTrials.gov